Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda

Обзор

This study will investigate the burden, causes, diagnostics, treatments and preventive measures related to meningitis in northern Uganda. We hypothesize that understanding the burden of meningitis, risk factors, diagnostics, treatments and the preventive measures will provide information regarding the gaps in care that can be addressed in order to improve the continuum of meningitis care. we hypothesize that our data will support the advocacy for the implementation of routine vaccination for the prevention of bacterial meningitis and improving guidelines for Cryptococcal antigen (CrAg) screening for prevention of cryptococcal meningitis, which will save lives in Uganda. Aim 1: To prospectively collect data on 1100 patients with meningitis and meningitis symptoms who were admitted to Lira Regional Referral Hospital (LRRH) to assess burden, etiologies, pathogenesis, and outcomes of meningitis using modern diagnostic testing not previously available in Uganda. Aim 2: To perform CrAg screening of 10,000 HIV-positive patients to determine the prevalence of cryptococcal antigenemia (infection) and conduct a case control study to compare risk factors and outcomes among CrAg-positive patients and matched CrAg-negative controls based on age, sex, TB status, ART experience, CD4 count, and viral load.

Вмешательства

• Диагностический тест Pastorex Latex Agglutination Test
  Rapid diagnosis of bacterial meningitis
• Диагностический тест Biofire PCR for meningitis
  Rapid diagnosis of multiple forms of meningitis
• Диагностический тест Immy CrAg Lateral Flow Assay
  Rapid diagnosis of cryptococcal meningitis

Первичные конечные точки

• number of participants with meningitis who died during hospitalization [Срок оценки: duration of hospitalization, approximately 2 weeks]
• number of participants with meningitis who died during the first 24 months after hospital admission [Срок оценки: 24 months]
• number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive [Срок оценки: 2 years]

Вторичные конечные точки (2)

• number of participants who develop overt cryptococcal meningitis [Срок оценки: 2 years]
• Number of participants with overt cryptococcal meningitis who die [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 1100 patients who present with meningitis or meningitis symptoms, regardless of age or vulnerably status are eligible for meningitis testing.
• 10,000 HIV-infected patients presenting to LRRH, LRRH HIV Clinic (LIDC) or nearby outpatient clinics, regardless of age or vulnerability status, are eligible for CrAg screening.

Критерии исключения

• Patients who are found not to have meningitis after initial evaluation, or are found to have other alternative diagnoses that explain their symptoms, will be excluded.
• HIV-negative patients without signs or symptoms of meningitis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Uganda · 1 центр

• Lira Regional Referral Hospital — Lira

Идентификаторы

NCT: NCT05496673 · STUDY00007296 · R21TW012439

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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